Sleep BruxismEMG_BRUXNCT06343194
Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism
A study testing Bruxoff ® in people with Sleep Bruxism and Masseter Muscle Hypertrophy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients. The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Masseter Muscle Hypertrophy, Grinding Teeth
- What is being tested?
- Bruxoff ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Acceptance of the treatment plan with clear aligners;
- Acceptance of informed consent to the study;
- Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine.
- Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health.
Who cannot join
- Patients with morphological and structural alterations to the temporomandibular joint, e.g. Condillary hypertrophy;
- Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia;
- Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity;
- Patients with pacemakers;
- Patients with periodontal diseases;
- Patients with ongoing orthodontic therapy or with prosthetic rehabilitation
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Clinica Odontoiatrica, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore
Rome, Lazio, 00168
About this study
Official title: Analysis of Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism: Single-centre Interventional Case-control With Device
The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.
The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.
Read more
The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.
The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.
- Conditions
- Sleep Bruxism, Masseter Muscle Hypertrophy, Grinding Teeth
- Being tested
- Bruxoff ®
- Keywords
- clear aligners, bruxoff, electromiograph, therapy, masseter muscle contraction, muscle pain
- Medical subject headings
- Sleep Bruxism, Masticatory Muscles, Hypertrophy of, Bruxism, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruxoff ®Device
Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| bruxism patients assessed with Bruxoff ® | Active comparator | Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine, i.e. if they have at least one of the following two points:
1. The subject reports or is aware of noises of grinding or clamping during sleep.
2. One or more of the following signs are present:
* Abnormal wear of teeth;
* Discomfort, fatigue or pain in the muscles of the face;
* Hypertrophy of muscles during voluntary clamping;
* Any abnormalities in the mandibular muscle activity cannot be expressed by other sleep disorders, medical, neurological, drug use or substance abuse;
* Bruxoff ® cut-off more than 4. Receives: Device: Bruxoff ® |
| non-bruxism patients assessed with Bruxoff ® | Active comparator | Subjects with good health, with no evidence of bruxism symptoms or signs. Bruxoff ® cut-off equal or less than 4. Receives: Device: Bruxoff ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in potentials recorded by Bruxoff ® in bruxism patients.
The primary outcome of the study is the change in potential recorded by Bruxoff®, defined as the variation in nocturnal masseter contraction activity just in bruxism patients treated with aligners.The study aims to evaluate and compare diagnostic records measured with the Bruxoff® at three time points. Each time, the Bruxoff® is used two nights in a row. The purpose of the first night's data collection is to help the patient learn how to apply and use the device to its fullest potential; only the data collected on the second night will be used in the study to determine whether or not the patient has bruxism.
- The Bruxoff® device is initially administered for two consecutive nights before the start of aligner therapy (T0).
- 2 months after starting clear aligner therapy (T1), Bruxoff® is given for two consecutive nights.
- The last 2 records are registered 6 months after the beginning of the treatment with clear aligners (T2).
Measured: The records with Bruxoff® device are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.
Secondary outcomes (1)
Change of signs and symptoms of bruxism
The secondary outcome consists in the mutation of signs (i.e. tooth wear) and symptoms (i.e. massetere muscles pain) of bruxism.
In order to evaluate how occlusal relationships have changed in bruxism patients treated with aligners at the three study times (T0, T1, T2), we compare their clinical condition with non-bruxism patients.
Furthermore, it's possible to measure the following characteristics during the three study times (T0, T1, and T2), both in the individual group and between patients with and without bruxism, using the Visual Analogue Scale (range 0-10):
- the mutation of the chewing muscles' pain and of the related migraines;
- the variation of the functional limitation during routine mandibular movements related to treatment with clear aligners.
Measured: The clinical examinations are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start31 Oct 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Waiting agreement for the use of electromiography in the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- bruxism patients and non-bruxism patients
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Cordaro, professor, Principal investigator, UOC Odontoiatria Generale e Ortodonzia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343194
- Sponsor's protocol ID
- 6162
- Acronym
- EMG_BRUX
- Status last verified
- Aug 2025
- First submitted
- 26 Mar 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lobbezoo F, Naeije M. Bruxism is mainly regulated centrally, not peripherally. J Oral Rehabil. 2001 Dec;28(12):1085-91. doi: 10.1046/j.1365-2842.2001.00839.x.
PubMed 11874505Ohlmann B, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Variability of sleep bruxism-findings from consecutive nights of monitoring. Clin Oral Investig. 2022 Apr;26(4):3459-3466. doi: 10.1007/s00784-021-04314-8. Epub 2021 Dec 3.
PubMed 34862565Ohlmann B, Rathmann F, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Validity of patient self-reports and clinical signs in the assessment of sleep bruxism based on home-recorded electromyographic/electrocardiographic data. J Oral Rehabil. 2022 Jul;49(7):720-728. doi: 10.1111/joor.13327. Epub 2022 Apr 11.
PubMed 35348247Manfredini D, Ahlberg J, Castroflorio T, Poggio CE, Guarda-Nardini L, Lobbezoo F. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies. J Oral Rehabil. 2014 Nov;41(11):836-42. doi: 10.1111/joor.12207. Epub 2014 Jul 8.
PubMed 25040303Castroflorio T, Bargellini A, Rossini G, Cugliari G, Deregibus A, Manfredini D. Agreement between clinical and portable EMG/ECG diagnosis of sleep bruxism. J Oral Rehabil. 2015 Oct;42(10):759-64. doi: 10.1111/joor.12320. Epub 2015 Jun 7.
PubMed 26059761Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
PubMed 23121262Lavigne GJ, Huynh N, Kato T, Okura K, Adachi K, Yao D, Sessle B. Genesis of sleep bruxism: motor and autonomic-cardiac interactions. Arch Oral Biol. 2007 Apr;52(4):381-4. doi: 10.1016/j.archoralbio.2006.11.017. Epub 2007 Feb 20.
PubMed 17313939Bader G, Lavigne G. Sleep bruxism; an overview of an oromandibular sleep movement disorder. REVIEW ARTICLE. Sleep Med Rev. 2000 Feb;4(1):27-43. doi: 10.1053/smrv.1999.0070.
PubMed 12531159Dube C, Rompre PH, Manzini C, Guitard F, de Grandmont P, Lavigne GJ. Quantitative polygraphic controlled study on efficacy and safety of oral splint devices in tooth-grinding subjects. J Dent Res. 2004 May;83(5):398-403. doi: 10.1177/154405910408300509.
PubMed 15111632Harada T, Ichiki R, Tsukiyama Y, Koyano K. The effect of oral splint devices on sleep bruxism: a 6-week observation with an ambulatory electromyographic recording device. J Oral Rehabil. 2006 Jul;33(7):482-8. doi: 10.1111/j.1365-2842.2005.01576.x.
PubMed 16774505Benli M, Ozcan M. Short-term effect of material type and thickness of occlusal splints on maximum bite force and sleep quality in patients with sleep bruxism: a randomized controlled clinical trial. Clin Oral Investig. 2023 Aug;27(8):4313-4322. doi: 10.1007/s00784-023-05049-4. Epub 2023 May 2.
PubMed 37127807Zheng M, Liu R, Ni Z, Yu Z. Efficiency, effectiveness and treatment stability of clear aligners: A systematic review and meta-analysis. Orthod Craniofac Res. 2017 Aug;20(3):127-133. doi: 10.1111/ocr.12177. Epub 2017 May 26.
PubMed 28547915Miller KB, McGorray SP, Womack R, Quintero JC, Perelmuter M, Gibson J, Dolan TA, Wheeler TT. A comparison of treatment impacts between Invisalign aligner and fixed appliance therapy during the first week of treatment. Am J Orthod Dentofacial Orthop. 2007 Mar;131(3):302.e1-9. doi: 10.1016/j.ajodo.2006.05.031.
PubMed 17346581Lou T, Tran J, Castroflorio T, Tassi A, Cioffi I. Evaluation of masticatory muscle response to clear aligner therapy using ambulatory electromyographic recording. Am J Orthod Dentofacial Orthop. 2021 Jan;159(1):e25-e33. doi: 10.1016/j.ajodo.2020.08.012. Epub 2020 Nov 21.
PubMed 33234460Ciavarella D, Fanelli C, Suriano C, Cazzolla AP, Campobasso A, Guida L, Laurenziello M, Illuzzi G, Tepedino M. Occlusal Plane Modification in Clear Aligners Treatment: Three Dimensional Retrospective Longitudinal Study. Dent J (Basel). 2022 Dec 27;11(1):8. doi: 10.3390/dj11010008.
PubMed 36661545
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism: Single-centre Interventional Case-control With Device
- ClinicalTrials.gov ID
- NCT06343194
- Acronym / sponsor ID
- EMG_BRUX / 6162
- Conditions
- Sleep Bruxism, Masseter Muscle Hypertrophy, Grinding Teeth
- Keywords
- clear aligners, bruxoff, electromiograph, therapy, masseter muscle contraction, muscle pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Waiting agreement for the use of electromiography in the hospital
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.
The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.
The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.
The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- bruxism patients and non-bruxism patients
| Arm | Type | Receives |
|---|---|---|
| bruxism patients assessed with Bruxoff ® | Active comparator | Device: Bruxoff ®Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine, i.e. if they have at least one of the following two points: 1. The subject reports or is aware of noises of grinding or clamping during sleep. 2. One or more of the following signs are present: * Abnormal wear of teeth; * Discomfort, fatigue or pain in the muscles of the face; * Hypertrophy of muscles during voluntary clamping; * Any abnormalities in the mandibular muscle activity cannot be expressed by other sleep disorders, medical, neurological, drug use or substance abuse; * Bruxoff ® cut-off more than 4. |
| non-bruxism patients assessed with Bruxoff ® | Active comparator | Device: Bruxoff ®Subjects with good health, with no evidence of bruxism symptoms or signs. Bruxoff ® cut-off equal or less than 4. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Acceptance of the treatment plan with clear aligners;
- Acceptance of informed consent to the study;
- Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine.
- Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health.
Key exclusion criteria (6 listed)
- Patients with morphological and structural alterations to the temporomandibular joint, e.g. Condillary hypertrophy;
- Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia;
- Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity;
- Patients with pacemakers;
- Patients with periodontal diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruxoff ®Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate. | Device | bruxism patients assessed with Bruxoff ®, non-bruxism patients assessed with Bruxoff ® |
Primary outcome
Change in potentials recorded by Bruxoff ® in bruxism patients.
Time frame: The records with Bruxoff® device are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.
The primary outcome of the study is the change in potential recorded by Bruxoff®, defined as the variation in nocturnal masseter contraction activity just in bruxism patients treated with aligners.The study aims to evaluate and compare diagnostic records measured with the Bruxoff® at three time points. Each time, the Bruxoff® is used two nights in a row. The purpose of the first night's data collection is to help the patient learn how to apply and use the device to its fullest potential; only the data collected on the second night will be used in the study to determine whether or not the patient has bruxism. * The Bruxoff® device is initially administered for two consecutive nights before the start of aligner therapy (T0). * 2 months after starting clear aligner therapy (T1), Bruxoff® is given for two consecutive nights. * The last 2 records are registered 6 months after the beginning of the treatment with clear aligners (T2).
1 secondary outcome
Change of signs and symptoms of bruxism
Time frame: The clinical examinations are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 11874505Lobbezoo F, Naeije M. Bruxism is mainly regulated centrally, not peripherally. J Oral Rehabil. 2001 Dec;28(12):1085-91. doi: 10.1046/j.1365-2842.2001.00839.x.
- Background: PubMed 34862565Ohlmann B, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Variability of sleep bruxism-findings from consecutive nights of monitoring. Clin Oral Investig. 2022 Apr;26(4):3459-3466. doi: 10.1007/s00784-021-04314-8. Epub 2021 Dec 3.
- Background: PubMed 35348247Ohlmann B, Rathmann F, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Validity of patient self-reports and clinical signs in the assessment of sleep bruxism based on home-recorded electromyographic/electrocardiographic data. J Oral Rehabil. 2022 Jul;49(7):720-728. doi: 10.1111/joor.13327. Epub 2022 Apr 11.
- Background: PubMed 25040303Manfredini D, Ahlberg J, Castroflorio T, Poggio CE, Guarda-Nardini L, Lobbezoo F. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies. J Oral Rehabil. 2014 Nov;41(11):836-42. doi: 10.1111/joor.12207. Epub 2014 Jul 8.
- Background: PubMed 26059761Castroflorio T, Bargellini A, Rossini G, Cugliari G, Deregibus A, Manfredini D. Agreement between clinical and portable EMG/ECG diagnosis of sleep bruxism. J Oral Rehabil. 2015 Oct;42(10):759-64. doi: 10.1111/joor.12320. Epub 2015 Jun 7.
- Background: PubMed 23121262Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
- Background: PubMed 17313939Lavigne GJ, Huynh N, Kato T, Okura K, Adachi K, Yao D, Sessle B. Genesis of sleep bruxism: motor and autonomic-cardiac interactions. Arch Oral Biol. 2007 Apr;52(4):381-4. doi: 10.1016/j.archoralbio.2006.11.017. Epub 2007 Feb 20.
- Background: PubMed 12531159Bader G, Lavigne G. Sleep bruxism; an overview of an oromandibular sleep movement disorder. REVIEW ARTICLE. Sleep Med Rev. 2000 Feb;4(1):27-43. doi: 10.1053/smrv.1999.0070.
- Background: PubMed 15111632Dube C, Rompre PH, Manzini C, Guitard F, de Grandmont P, Lavigne GJ. Quantitative polygraphic controlled study on efficacy and safety of oral splint devices in tooth-grinding subjects. J Dent Res. 2004 May;83(5):398-403. doi: 10.1177/154405910408300509.
- Background: PubMed 16774505Harada T, Ichiki R, Tsukiyama Y, Koyano K. The effect of oral splint devices on sleep bruxism: a 6-week observation with an ambulatory electromyographic recording device. J Oral Rehabil. 2006 Jul;33(7):482-8. doi: 10.1111/j.1365-2842.2005.01576.x.
- Background: PubMed 37127807Benli M, Ozcan M. Short-term effect of material type and thickness of occlusal splints on maximum bite force and sleep quality in patients with sleep bruxism: a randomized controlled clinical trial. Clin Oral Investig. 2023 Aug;27(8):4313-4322. doi: 10.1007/s00784-023-05049-4. Epub 2023 May 2.
- Background: PubMed 28547915Zheng M, Liu R, Ni Z, Yu Z. Efficiency, effectiveness and treatment stability of clear aligners: A systematic review and meta-analysis. Orthod Craniofac Res. 2017 Aug;20(3):127-133. doi: 10.1111/ocr.12177. Epub 2017 May 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Cordaro, professor principal investigator
UOC Odontoiatria Generale e Ortodonzia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bruxoff ® in people with Sleep Bruxism and Masseter Muscle Hypertrophy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in potentials recorded by Bruxoff ® in bruxism patients. (time frame: The records with Bruxoff® device are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343194, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.